New Seasons Market Issues Allergy Alert on Undeclared Egg in Packaged Macaroni and Cheese - FDA Safety Alerts & Drug Recalls

New Seasons Market has initiated a voluntary recall of its New Seasons Market Grab and Go pre-packaged Macaroni and Cheese because it may contain undeclared egg. People who have an allergy or severe sensitivity to eggs run the risk of an allergic reaction if they consume this product.

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Daisy’s Bakery Inc. Issues Alert On Undeclared Milk In “Gourmet Concha” - FDA Safety Alerts & Drug Recalls

Daisy’s Bakery Inc. of Clifton, New Jersey is recalling 4 ounce packages of Gourmet Concha, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

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FDA permits marketing of device to treat diabetic foot ulcers - FDA Press Releases

FDA permits marketing of device to treat diabetic foot ulcers

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Changing Healthcare Service Delivery to Improve Health Outcomes For Older Adults: Opportunities Not to Be Missed - American Geriatric Society

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Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Linezolid Injection 600mg/300ml, due to Presence White Particulate Matter that has been Identified as Mold - FDA Safety Alerts & Drug Recalls

AuroMedics Pharma LLC is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August 2018 to the hospital level. This batch was distributed May 15 through August 14, 2017. The product was found to contain white particulate matter that has been identified as mold. This problem was discovered as a result of a product complaint in which the contents of one flexible bag from one batch CLZ160007 was found to contain white particulate matter.

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Statement from FDA Commissioner Scott Gottlieb, M.D. on efforts to support more efficient and effective food recalls - FDA Press Releases

FDA discusses the steps taken to improve the recall process, the HHS OIG report on recalls, and new policies being considered.

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Nodine's Smokehouse Inc. is Recalling Smoked Salmon 1.5 lbs, 8 oz Packages Due to Possible Listeria Monocytogenes Contamination - FDA Safety Alerts & Drug Recalls

Nodine's Smokehouse, Inc. of Torrington, Connecticut is recalling Smoked Salmon 1.5 lbs, 8 oz packages. Lot numbers 40173 and 33173 because they have the potential to be contaminated with Listeria monocytogenes. Consumption of food contaminated with Listeria monocytogenes can cause listeriosis, with high fever, severe headache, neck stiffness, and nausea as its primary symptoms. In rare cases, listeriosis is fatal; it can also cause miscarriages and stillbirths. People experiencing these problems should seek immediate medical attention. Pregnant women the very young, elderly, and persons with compromised immune systems are the most susceptible.

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Temporal Trends in Analgesic Use in Long-Term Care Facilities: A Systematic Review of International Prescribing - American Geriatric Society

Objectives

To explore global changes in the prescription of analgesic drugs over time in the international long-term care (LTC) population.

Design

Systematic review.

Setting

We included original research articles in English, published and unpublished, that included number of participants, country and year(s) of data collection, and prescription of analgesics (analgesics not otherwise specified, opioids, acetaminophen; scheduled only, or scheduled plus as needed (PRN)).

Participants

LTC residents.

Measurements

We searched PubMed, EMBASE, CINAHL, International Pharmaceutical Abstracts, PsycINFO, Cochrane, Web of Science, Google Scholar, using keywords for LTC facilities and analgesic medication; hand-searched references of eligible papers; correspondence. Studies were quality rated using an adapted Newcastle-Ottawa scale. Pearson correlation coefficients were generated between percentage of residents prescribed an analgesic and year of data collection. If available, we investigated changes in acetaminophen and opioid prescriptions.

Results

Forty studies met inclusion criteria. A moderate correlation (0.59) suggested that scheduled prescription rates for analgesics have increased over time. Similar findings were reflected in scheduled prescriptions for acetaminophen and opioids. No increase was seen when analyzing scheduled plus PRN analgesics. Use of opioids (scheduled plus PRN) appears to have increased over time.

Conclusion

Worldwide, use of opioids and acetaminophen has increased in LTC residents. Research is needed to explore whether this reflects appropriate pain management for LTC residents and if PRN medication is used effectively.

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Voluntary Recall on Harris Teeter’s HT Traders Mama Biscotti Mini Biscotti – Triple Chocolate - FDA Safety Alerts & Drug Recalls

Harris Teeter is notifying 153 shoppers who purchased HT Traders Mama Biscotti Mini Biscotti – Triple Chocolate since Dec. 8, 2017. The company’s supplier, Mom’s Best Gourmet Foods, Inc., is issuing a voluntary recall due to potential undeclared almonds and hazelnuts. The company has notified the shoppers for which it has customer data via telephone and email; the company hopes this statement will reach any shoppers for which the company does not have customer data.

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FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response - FDA Press Releases

FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response

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Fresh Pak Inc. Recalls Lot Specific Sliced Apple Products Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Fresh Pak Inc. of Detroit, MI is announcing a voluntary Lot specific recall of red/green apple slices. Jack Brown Produce, Inc. (supplier) requested Fresh Pak Inc. to perform a recall for the reason that they could have potentially been contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short‐term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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FDA clears stereotactic radiotherapy system for use in treating breast cancer - FDA Press Releases

FDA clears stereotactic radiotherapy system for use in treating breast cancer

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Telephone Follow-Up for Older Adults Discharged to Home from the Emergency Department: A Pragmatic Randomized Controlled Trial - American Geriatric Society

Background/Objectives

Telephone calls after discharge from the emergency department (ED) are increasingly used to reduce 30-day rates of return or readmission, but their effectiveness is not established. The objective was to determine whether a scripted telephone intervention by registered nurses from a hospital-based call center would decrease 30-day rates of return to the ED or hospital or of death.

Design

Randomized, controlled trial from 2013 to 2016.

Setting

Large, academic medical center in the southeast United States.

Participants

Individuals aged 65 and older discharged from the ED were enrolled and randomized into intervention and control groups (N = 2,000).

Intervention

Intervention included a telephone call from a nurse using a scripted questionnaire to identify obstacles to elements of successful care transitions: medication acquisition, postdischarge instructions, and obtaining physician follow-up. Control subjects received a satisfaction survey only.

Measurements

Primary outcome was return to the ED, hospitalization, or death within 30 days of discharge from the ED.

Results

Rate of return to the ED or hospital or death within 30 days was 15.5% (95% confidence interval (CI) = 13.2–17.8%) in the intervention group and 15.2% (95% CI = 12.9–17.5%) in the control group (P = .86). Death was uncommon (intervention group, 0; control group, 5 (0.51%), 95% CI = 0.06–0.96%); 12.2% of intervention subjects (95% CI = 10.1–14.3%) and 12.5% of control subjects (95% CI = 10.4–14.6%) returned to the ED, and 9% of intervention subjects (95% CI = 7.2–10.8%) and 7.4% of control subjects (95% CI = 5.8–9.0%) were hospitalized within 30 days.

Conclusion

A scripted telephone call from a trained nurse to an older adult after discharge from the ED did not reduce ED or hospital return rates or death within 30 days. Clinicaltrials.gov identifier: NCT01893931z.

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Improving Emergency Department Discharge Care with Telephone Follow-Up. Does It Connect? - American Geriatric Society

This editorial comments on the article by Biese et al.

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FDA approves drug to treat dangerously low blood pressure - FDA Press Releases

The FDA today approved the new drug Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock.

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Corrected: Springfield Smoked Fish Expands their Recall of Smoked Salmon Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Springfield Smoked Fish of Springfield, MA is expanding their voluntary recall to include additional smoked fish and cream cheese products because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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Meijer Voluntarily Recalls Select Meijer Brand Fresh Packaged Products Containing Apples Due to Potential Health Risk - FDA Safety Alerts & Drug Recalls

As a result of the Fresh-Pak Inc. recall, Meijer is announcing a voluntary recall of select Meijer brand packaged products due to sliced apples within the products being potentially contaminated with Listeria monocytogenes. To date, there have been no known illnesses reported in connection with this recall.

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Corrigendum: Structures and biological activities of novel 4′-acetylated analogs of chrysomycins A and B - Journal of Antibiotics

Corrigendum: Structures and biological activities of novel 4′-acetylated analogs of chrysomycins A and B

Corrigendum: Structures and biological activities of novel 4′-acetylated analogs of chrysomycins A and B, Published online: 20 December 2017; doi:10.1038/ja.2017.128

Corrigendum: Structures and biological activities of novel 4′-acetylated analogs of chrysomycins A and B

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Winners of the 2016 JA Medals for excellence - Journal of Antibiotics

Winners of the 2016 JA Medals for excellence

Winners of the 2016 JA Medals for excellence, Published online: 20 December 2017; doi:10.1038/ja.2017.133

Winners of the 2016 JA Medals for excellence

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Acknowledgments - Journal of Antibiotics

Acknowledgments

Acknowledgments, Published online: 20 December 2017; doi:10.1038/ja.2017.134

Acknowledgments

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Influence of Poor Oral Health on Physical Frailty: A Population-Based Cohort Study of Older British Men - American Geriatric Society

Objectives

To investigate the associations between objective and subjective measures of oral health and incident physical frailty.

Design

Cross-sectional and longitudinal study with 3 years of follow-up using data from the British Regional Heart Study.

Setting

General practices in 24 British towns.

Participants

Community-dwelling men aged 71 to 92 (N = 1,622).

Measurements

Objective assessments of oral health included tooth count and periodontal disease. Self-reported oral health measures included overall self-rated oral health; dry mouth symptoms; sensitivity to hot, cold, and sweet; and perceived difficulty eating. Frailty was defined using the Fried phenotype as having 3 or more of weight loss, grip strength, exhaustion, slow walking speed, and low physical activity. Incident frailty was assessed after 3 years of follow-up in 2014.

Results

Three hundred three (19%) men were frail at baseline (aged 71–92). Having fewer than 21 teeth, complete tooth loss, fair to poor self-rated oral health, difficulty eating, dry mouth, and more oral health problems were associated with greater likelihood of being frail. Of 1,284 men followed for 3 years, 107 (10%) became frail. The risk of incident frailty was higher in participants who were edentulous (odds ratio (OR) = 1.90, 95% confidence interval (CI) = 1.03–3.52); had 3 or more dry mouth symptoms (OR = 2.03, 95% CI = 1.18–3.48); and had 1 (OR = 2.34, 95% CI = 1.18–4.64), 2 (OR = 2.30, 95% CI = 1.09–4.84), or 3 or more (OR = 2.72, 95% CI = 1.11–6.64) oral health problems after adjustment for age, smoking, social class, history of cardiovascular disease or diabetes mellitus, and medications related to dry mouth.

Conclusion

The presence of oral health problems was associated with greater risks of being frail and developing frailty in older age. The identification and management of poor oral health in older people could be important in preventing frailty.

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Oral Health in Healthy Aging - American Geriatric Society

This editorial comments on the articles by Ramsay et al, Kossioni et al, and Joseph M. Mylotte.

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Will Maintenance of Oral Hygiene in Nursing Home Residents Prevent Pneumonia? - American Geriatric Society

This article is an evaluation of the literature on oral hygiene as a risk factor for nursing home–associated pneumonia (NHAP) and with interventions to improve oral hygiene and reduce the incidence of NHAP. The background for this article is that studies that have evaluated interventions to improve oral hygiene and prevent NHAP have conflicting results. To try to understand the reason for these results, the objective was to examine risk factor and intervention studies and determine their methodological validity. Review of studies evaluating oral hygiene status as a risk factor for NHAP found multiple methodological problems, resulting in limited evidence to support this association. Studies of intervention methods, whether finding benefit or not in preventing NHAP, all had methodological limitations. Therefore, it is unclear whether oral hygiene is a risk factor for NHAP and whether improving oral hygiene decreases the incidence of this infection. A recommendation is made that future studies should carefully define the etiology of suspected NHAP using molecular techniques when evaluating methods to prevent this infection because viral pneumonia and aspiration pneumonitis may mimic bacterial pneumonia even though, at times, there may be coinfection with bacteria. In this latter situation, improving oral hygiene may not prevent pneumonia. Therefore, viral infection and pneumonitis with or without bacterial coinfection need to be excluded so that the focus is on prevention of bacterial pneumonia.

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An Expert Opinion from the European College of Gerodontology and the European Geriatric Medicine Society: European Policy Recommendations on Oral Health in Older Adults - American Geriatric Society

This is an expert opinion paper on oral health policy recommendations for older adults in Europe, with particular focus on frail and care-dependent persons, that the European College of Gerodontology (ECG) and the European Geriatric Medicine Society (EUGMS) Task and Finish Group on Gerodontology has developed. Oral health in older adults is often poor. Common oral diseases such as caries, periodontal disease, denture-related conditions, hyposalivation, and oral pre- and cancerous conditions may lead to tooth loss, pain, local and systemic infection, impaired oral function, and poor quality of life. Although the majority of oral diseases can be prevented or treated, oral problems in older adults remain prevalent and largely underdiagnosed, because frail persons often do not receive routine dental care, due to a number of barriers and misconceptions. These hindrances include person-related issues, lack of professional support, and lack of effective oral health policies. Three major areas for action are identified: education for healthcare providers, health policy action plans, and citizen empowerment and involvement. A list of defined competencies in geriatric oral health for non-dental healthcare providers is suggested, as well as an oral health promotion and disease prevention protocol for residents in institutional settings. Oral health assessment should be incorporated into general health assessments, oral health care should be integrated into public healthcare coverage, and access to dental care should be ensured.

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Springfield Smoked Fish Expands their Recall of Smoked Salmon Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Springfield Smoked Fish of Springfield, MA is expanding their voluntary recall of smoked fish products because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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Gel Spice Company, Inc. Issues Allergy Alert On Undeclared Soy And Wheat In Beef Flavored Bouillon Cube Products. - FDA Safety Alerts & Drug Recalls

Gel Spice Company, Inc. is voluntarily recalling certain Spice Time and Spice Supreme Beef Flavored Bouillon Cube products (identified below) because they contain undeclared soy and wheat. People who have an allergy or severe sensitivity to soy and/or wheat run the risk of serious or life-threatening allergic reaction(s) if they consume these products.

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AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Pantoprazole Sodium for Injection 40 Mg Per Vial, Due to Presence of Glass Particles in the Vial. - FDA Safety Alerts & Drug Recalls

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial, to the hospital level. The product was found to contain glass particles in the vial. This problem was discovered as a result of a product complaint in which the contents of one vial from one batch was found to contain a piece of glass.

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Jack Brown Produce, Inc. Recalls Gala, Fuji, Honeycrisp and Golden Delicious Apples Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Jack Brown Produce, Inc. of Sparta, MI is recalling Gala, Fuji, Honeycrisp and Golden Delicious apples processed and shipped by one of its suppliers, Nyblad Orchards, Inc., on December 11 through December 16, 2017, because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss - FDA Press Releases

FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss

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Meta-analysis of Interventions to Reduce Adverse Drug Reactions in Older Adults - American Geriatric Society

Objectives

To examine the effect of interventions to optimize medication use on adverse drug reactions (ADRs) in older adults.

Design

Systematic review and meta-analysis. EMBASE, PubMed, OVID, Cochrane Library, Clinicaltrials.gov, and Google Scholar were searched through April 30, 2017.

Setting

Randomized controlled trials.

Participants

Older adults (mean age ≥65) taking medications.

Measurements

Two authors independently extracted relevant information and assessed studies for risk of bias. Discrepancies were resolved in consensus meetings. The outcomes were any and serious ADRs. Random-effects models were used to combine the results of multiple studies and create summary estimates.

Results

Thirteen randomized controlled trials involving 6,198 older adults were included. The studies employed a number of different interventions that were categorized as pharmacist-led interventions (8 studies), other health professional-led interventions (3 studies), a brief educational session (1 study), and a technology intervention (1 study). The intervention group was 21% less likely than the control group to experience any ADR (odds ratio (OR) = 0.79, 95% confidence interval (CI) = 0.62–0.99). In the six studies that examined serious ADRs, the intervention group was 36% less likely than the control group to experience a serious ADR (OR = 0.64, 95% CI = 0.42–0.98).

Conclusion

Interventions designed to optimize medication use reduced the risk of any and serious ADRs in older adults. Implementation of these successful interventions in healthcare systems may improve medication safety in older adults.

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FDA proposes new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs - FDA Press Releases

Today, the U.S. Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.

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Handing Off the Older Patient: Improved Documentation of Geriatric Assessment in Transitions of Care - American Geriatric Society

Objectives

To improve assessment and documentation of function, cognition, and advance care planning (ACP) in admission and discharge notes on an Acute Care of the Elderly (ACE) unit.

Design

Continuous quality improvement intervention with episodic data review.

Setting

ACE unit of an 866-bed academic tertiary hospital.

Participants

Housestaff physicians rotating on the ACE unit (N = 31).

Intervention

Introduction of templated notes, housestaff education, leadership outreach, and posted reminders.

Measurements

Documentation of function, cognition, and ACP were assessed through chart review of a weekly sample of the ACE unit census and scored using predefined criteria.

Results

Medical records (N = 172) were reviewed. At baseline, 0% of admission and discharge notes met minimum documentation criteria for all 3 domains (function, cognition, ACP). Documentation of function and cognition was completely absent at baseline. After the intervention, there was marked improvement in all measures, with 64% of admission notes and 94% of discharge notes meeting minimum documentation criteria or better in all 3 domains.

Conclusion

A quality improvement intervention using geriatric-specific note templates, housestaff training, and reminders increased documentation of function, cognition and ACP for postacute care.

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Racial Disparities in Hospice Outcomes: A Race or Hospice-Level Effect? - American Geriatric Society

Objectives

To determine whether there is racial variation in hospice enrollees in rates of hospitalization and hospice disenrollment and, if so, whether systematic differences in hospice provider patterns explain the variation.

Design

Longitudinal cohort study.

Setting

Hospice.

Participants

Medicare beneficiaries (N = 145,038) enrolled in a national random sample of hospices (N = 577) from the National Hospice Survey and followed until death (2009–10).

Measurements

We used Medicare claims data to identify hospital admissions, emergency department (ED) visits, and hospice disenrollment after hospice enrollment. We used a series of hierarchical models including hospice-level random effects to compare outcomes of blacks and whites.

Results

In unadjusted models, black hospice enrollees were significantly more likely than white enrollees to be admitted to the hospital (14.9% vs 8.7%, odds ratio (OR) = 1.84, 95% confidence interval (CI) = 1.74–1.95), visit the ED (19.8% vs 13.5%, OR = 1.58, 95% CI = 1.50–1.66), and disenroll from hospice (18.1% vs 13.0%, OR = 1.48, 95% CI = 1.40–1.56). These results were largely unchanged after accounting for participant clinical and demographic covariates and hospice-level random effects. In adjusted models, blacks were at higher risk of hospital admission (OR = 1.75, 95% CI = 1.64–1.86), ED visits (OR = 1.61, 95% CI = 1.52–1.70), and hospice disenrollment (OR = 1.54, 95% CI = 1.45–1.63).

Conclusion

Racial differences in intensity of care at the end of life are not attributable to hospice-level variation in intensity of care. Differences in patterns of care between black and white hospice enrollees persist within the same hospice.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA efforts to support more efficient development of targeted therapies - FDA Press Releases

FDA issues two draft guidances that will provide medical product developers with greater clarity on the FDA’s recommendations for researching and developing the next generation of individualized therapies.

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Marmex Corp Issues Voluntary Nationwide Recall Of Blue Pearl All Natural Male Enhancement Supplement, Due To Undeclared Sildenafil - FDA Safety Alerts & Drug Recalls

Orange, CA, Marmex Corp is voluntarily recalling All lots of Blue Pearl All Natural Male Enhancement Supplement, 500mg to the consumer level. FDA analysis has found the products to contain sildenafil.

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Springfield Smoked Fish Recalls Smoked Salmon Because Of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Springfield Smoked Fish of Springfield, Ma.is recalling its 1lb. packages Prescliced Nova Salmon because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea.

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FDA launches new tool for sharing information that allows doctors to better manage antibiotic use; improve patient care - FDA Press Releases

Today the FDA is announcing a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to combat antimicrobial resistance. The agency created a website that will provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug.

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FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome - FDA Press Releases

FDA approves first drug for a rare autoimmune disease that causes an inflammation in the wall of blood vessels of the body. This is a new indication for a previously-approved drug.

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FDA warns companies for promoting alternatives to street drugs - FDA Press Releases

The FDA today posted a warning letter to the marketers and distributors of Legal Lean Syrup, a drink, and Coco Loko, a “snortable” chocolate powder, for selling unapproved new drugs and misbranded drugs.

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Prospective Validation of a Screening Tool to Identify Older Adults in Need of a Driving Evaluation - American Geriatric Society

Objectives

To prospectively validate and refine the 5-item “CRASH” screening tool for identifying older drivers needing a behind-the-wheel (BTW) test.

Design

Prospective observational study.

Setting

Geriatric and internal medicine primary care clinics affiliated with a tertiary care hospital and a local BTW program.

Participants

Cognitively intact drivers aged 65 and older (N = 315).

Measurements

Participants completed baseline questionnaire (including CRASH tool) and assessments and BTW test (evaluator blinded to questionnaire results) and participated in 1-month telephone follow-up. Analysis included descriptive statistics and examination of predictive ability of the CRASH tool to discriminate normal (pass) from abnormal (conditional pass or fail) on the BTW test, with logistic regression and CART techniques for tool refinement.

Results

Two hundred sixty-six participants (84%) had a BTW test; of these, 17% had a normal rating and 83% an abnormal rating. Forty-five percent of those with an abnormal score were advised to limit driving under particular conditions. Neither the CRASH tool nor its individual component variables were significantly associated with the summary BTW score; in refined models with other variables, the best-performing tool had approximately 67% sensitivity and specificity for an abnormal BTW score. Most participants found the BTW test useful and were willing to pay a median of $50. At 1-month follow-up, no participants had stopped driving.

Conclusion

The CRASH screening tool cannot be recommended for use in clinical practice. Findings on older adults' perceived utility of the BTW test and the stability of driving patterns at 1-month follow-up could be useful for future research studies and for design of older driver programs.

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Symptoms Reported by Frail Elderly Adults Independently Predict 30-Day Hospital Readmission or Emergency Department Care - American Geriatric Society

Objectives

To assess the degree to which self-reported symptoms predict unplanned readmission or emergency department (ED) care within 30 days of high-risk, elderly adults enrolled in a posthospitalization care transition program (CTP).

Design

Retrospective cohort study.

Setting

Posthospitalization CTP at Mayo Clinic, Rochester, Minnesota, from January 1, 2013, through March 3, 2015.

Participants

Frail, elderly adults (N = 230; mean age 83.5 ± 8.3, 46.5% male).

Measurements

Charlson Comorbidity Index (CCI) and self-reported symptoms, measured using the Edmonton Symptom Assessment System (ESAS), were ascertained upon CTP enrollment.

Results

Mean CCI was 3.9 ± 2.3. Of 51 participants returning to the hospital within 30 days of discharge, 13 had ED visits, and 38 were readmitted. Age, sex, and CCI were not significantly different between returning and nonreturning participants, but returning participants were significantly more likely to report shortness of breath (P = .004), anxiety (P = .02), depression (P = .02), and drowsiness (P = .01). Overall ESAS score was also a significant predictor of hospital return (P = .01).

Conclusion

Four self-reported symptoms and overall ESAS score, but not CCI, ascertained after hospital discharge were strong predictors of hospital return within 30 days. Including symptoms in risk stratification of high-risk elderly adults may help target interventions and reduce readmissions.

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FDA approves Admelog, the first short-acting "follow-on" insulin product to treat diabetes - FDA Press Releases

The FDA today approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Admelog is the first short-acting insulin approved as a “follow-on” product.

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FDA launches public education campaign to encourage adult smokers trying to quit cigarettes - FDA Press Releases

Today, the U.S. Food and Drug Administration announced an adult smoking cessation education campaign aimed at encouraging cigarette smokers to quit through messages of support that underscore the health benefits of quitting. These messages will be displayed in and around gas stations and convenience stores – retail locations where smokers face a multitude of triggers and that typically feature cigarette advertisements. The “Every Try Counts” campaign targets smokers ages 25-54 who have attempted to quit smoking in the last year but were unsuccessful. The two-year campaign launches next month in 35 U.S. markets and features print, digital, radio, and out-of-home ads, such as on billboards.

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My Mom is Dead (and that is OK) - American Geriatric Society

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Harvesters Issues Safety Alert on Bibi Frutix Candy Possible Chemical Contamination - FDA Safety Alerts & Drug Recalls

On Tuesday, December 5, a partner food pantry agency in Wamego, Kansas notified Harvesters—The Community Food Network of potentially contaminated Bibi Frutix candy product it received through Harvesters' distribution program. The candy product is likely contaminated with a chemical substance and is potentially harmful if eaten.

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ALDI Voluntarily Recalls Choceur Dark Chocolate Bar Due to Undeclared Nut Allergen Products Could Contain Almond Pieces Not Listed on Packaging - FDA Safety Alerts & Drug Recalls

In cooperation with Hofer KG ZNL Schokoladefab, ALDI has voluntarily recalled Choceur Dark Chocolate Bars as a precautionary measure due to the potential presence of almond pieces not listed on packaging. The recall was initiated after an ALDI employee identified almond pieces in the product. This product may cause an allergic reaction in customers who have a nut allergy.

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Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. Senate Committee on Health, Education, Labor & Pensions Hearing, “Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical Innovation - FDA Press Releases

FDA Commissioner Gottlieb testifies before the U.S. Senate Committee on Health, Education, Labor & Pensions on the agency’s implementation of the 21st Century Cures Act

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Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation

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Creative Contract Packaging LLC Issues An Allergen Alert Regarding 4 Ounce Jars Of Herb-Ox® Beef Flavor Granulated Bouillon Due To Potential Presence Of Undeclared Milk - FDA Safety Alerts & Drug Recalls

Creative Contract Packaging LLC is voluntarily recalling 4,412 cases, or 13,236 total pounds, of two code dates of HERB-OX® Beef Flavor Granulated Bouillon, due to the potential presence of an undeclared milk allergen.

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Utility of a Precision Medicine Test in Elderly Adults with Symptoms Suggestive of Coronary Artery Disease - American Geriatric Society

Background

Diagnosing obstructive coronary artery disease (CAD) is challenging in elderly adults, and current diagnostic approaches for CAD expose these individuals to risks from contrast dye and invasive procedures.

Design

A Registry to Evaluate Patterns of Care Associated with the Use of Corus CAD in Real World Clinical Care Settings (PRESET; NCT01677156), pragmatic clinical trial.

Setting

Community, 21 primary care practices.

Participants

Of 566 stable, nonacute outpatients presenting with symptoms suggestive of obstructive CAD, the 176 who were aged 65 and older (median age 70, 61% female) were the current study participants.

Intervention

Blood-based precision medicine test, incorporating age, sex, and gene expression score (ASGES) to improve clinical decision-making and quality of care.

Measurements

Information on demographic characteristics, clinical factors, ASGES results (range 1–40; low (≤15), high (>15)), referral patterns to cardiology and advanced cardiac testing, and major adverse cardiac events (MACEs) was collected in a subgroup analysis of elderly adults in the PRESET Registry. Follow-up was for 1 year after ASGES testing.

Results

Median ASGES was 25, and 40 (23%) participants had a low score. Clinicians referred 12.5% of participants with a low ASGES and 49.3% with a high ASGES to cardiology or advanced cardiac testing (odds ratio for referral = 0.12, P < .001, adjusted for participants demographics and clinical covariates). Higher scores were associated with greater likelihood of posttest cardiac referral. At 1-year follow-up, the incidence of a MACE or revascularization was 10% (13/136) in the high ASGES group and 0% (0/40) in the low ASGES group (P = .04).

Conclusion

The ASGES test showed potential clinical utility in the evaluation of elderly outpatients with symptoms suggestive of obstructive CAD. Test use may reduce unnecessary referrals and the risk of procedure-related complications in individuals with low ASGES, who are unlikely to benefit from further testing, while also identifying individuals who may benefit from further cardiac evaluation and management.

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Simple Diagnostics, Inc. Issues Voluntary Nationwide Recall of Foshan Flying Medical Alcohol Pads Due to the Lack of Sterility Assurance and Other Quality Issues - FDA Safety Alerts & Drug Recalls

Simple Diagnostics, is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were manufactured by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues.

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Response to Dr. Clarfield - American Geriatric Society

This is a response to the article by Clarfield.

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Response to Dr. Olshansky - American Geriatric Society

This is a response to the article by Olshansky.

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Healthy Life Expectancy Is Expanding - American Geriatric Society

See the response from Olshansky.

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The Future of Health - American Geriatric Society

See the response from Clarfield.

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Recognition of Delirium Features in Clinical Practice: Data from the “Delirium Day 2015” National Survey - American Geriatric Society

Background/Objectives

Delirium is underrecognized in clinical practice. The primary aim of the present multicenter study was to compare the ability of nurses to identify delirium features with a standardized assessment. The secondary aim was to identify predictors of missed or incorrect identifications of delirium by nurses.

Design

Point prevalence study in 120 wards across Italy.

Setting

“Delirium Day 2015.”

Participants

Inpatients aged 65 and older (N = 1,867).

Measurements

Participants and nurses were asked specific questions to investigate their perceptions of the presence of delirium features (acute cognitive change, inattention, cognitive fluctuations, impaired arousal). Delirium was identified according to the results of the Assessment Test for Delirium and Cognitive Impairment (4AT), completed by a physician. Comorbidities including dementia, disability, drug treatments, and delirium motor subtype according to the Delirium Motor Subtype Scale were recorded.

Results

Delirium was present in 429 subjects (23%) according to the 4AT. Cognitive fluctuations was the delirium feature that the nurses most often recognized. Nurses’ perceptions of acute cognitive change, cognitive fluctuations, or impaired arousal had 84% sensitivity and 81% specificity for delirium. The nonmotor subtype of delirium was less likely to be recognized (80%) than the hyperactive (97%), mixed (92%), and hypoactive (90%) subtypes. Incorrect perception of delirium was more frequent in subjects with dementia (specificity 64%).

Conclusions

The delirium feature that nurses were best able to recognize was cognitive fluctuations. The nonmotor subtype was associated with a lower recognition rate. Routine observation and registration of delirium features by nurses in clinical practice might be helpful to increase formal diagnosis of delirium.

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FDA Alerts Consumers to Recall of Certain Comforts FOR BABY Water with Fluoride - FDA Safety Alerts & Drug Recalls

The Kroger Company has recalled Comforts FOR BABY Purified Water with Fluoride Added 1 GAL (3.78 L) with sell by dates from 4/26/2018 to 10/10/2018, after receiving complaints about mold in the product. Testing by Kroger has identified the mold as Talaromyces penicillium. The water is sold in clear containers, but the mold may not be visible with the naked eye.

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Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA ushering in new era of 3D printing of medical products; provides guidance to manufacturers of medical devices - FDA Press Releases

The FDA is issuing final guidance on the technical considerations for the 3D printing of medical devices. The recommendations clarify what the FDA recommends manufacturers include in submissions for 3D printed medical products.

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Report and Research Agenda of the American Geriatrics Society and National Institute on Aging Bedside-to-Bench Conference on Urinary Incontinence in Older Adults: A Translational Research Agenda for a Complex Geriatric Syndrome - American Geriatric Society

The American Geriatrics Society, with support from the National Institute on Aging and other funders, held its ninth Bedside-to-Bench research conference, entitled “Urinary Incontinence in the Older Adult: A Translational Research Agenda for a Complex Geriatric Syndrome,” October 16 to 18, 2016, in Bethesda, Maryland. As part of a conference series addressing three common geriatric syndromes—delirium, sleep and circadian rhythm disturbance, and urinary incontinence—the series highlighted relationships and pertinent clinical and pathophysiological commonalities between these conditions. The conference provided a forum for discussing current epidemiology, basic science, and clinical and translational research on urinary incontinence in older adults; for identifying gaps in knowledge; and for developing a research agenda to inform future investigative efforts. The conference also promoted networking involving emerging researchers and thought leaders in the field of incontinence, aging, and other fields of research, as well as National Institutes of Health program personnel.

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FDA approves first biosimilar for the treatment of certain breast and stomach cancers - FDA Press Releases

FDA approves first biosimilar for the treatment of certain breast and stomach cancers

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